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Jade Plus

by OrbusNeich Medical (Shenzhen) Co., Ltd 249 variants

Ref 5840-040-32, 5825-015-22, 5850-120-22, 5860-060-22, 5830-120-22, 5855-240-22, 5860-150-12, 5845-150-22, 5955-180-12, 5855-080-12, 5960-120-12, 5840-020-12, 5970-150-12, 5815-300-12, 60100-060-22, 6050-300-32, 5840-180-12, 5840-020-22, 5825-080-22, 5835-120-12, 5820-300-32, 6030-240-22, 6060-040-12, 5845-015-12, 5930-080-12, 5825-100-32, 5820-060-32, 5925-180-12, 5925-040-22, 5960-060-32, 6060-180-22, 6040-080-32, 5815-080-22, 5935-180-12, 5820-020-32, 5945-015-22, 5815-020-32, 5815-120-12, 5840-240-12, 5945-060-12, 5860-180-32, 5820-100-32, 6040-060-32, 5925-240-22, 6060-300-22, 5830-120-12, 60120-040-22, 5830-180-22, 6080-150-22, 6050-040-12, 6080-060-22510(k) K202231

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202231↗

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number069349559582GZ Basic UDI-DI Date4 Jul 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202231 Date10 Dec 2020ClearedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
JADE PLUS Balloon Dilatation Catheter
Model / Reference
5840-040-32, 5825-015-22, 5850-120-22, 5860-060-22, 5830-120-22, 5855-240-22, 5860-150-12, 5845-150-22, 5955-180-12, 5855-080-12, 5960-120-12, 5840-020-12, 5970-150-12, 5815-300-12, 60100-060-22, 6050-300-32, 5840-180-12, 5840-020-22, 5825-080-22, 5835-120-12, 5820-300-32, 6030-240-22, 6060-040-12, 5845-015-12, 5930-080-12, 5825-100-32, 5820-060-32, 5925-180-12, 5925-040-22, 5960-060-32, 6060-180-22, 6040-080-32, 5815-080-22, 5935-180-12, 5820-020-32, 5945-015-22, 5815-020-32, 5815-120-12, 5840-240-12, 5945-060-12, 5860-180-32, 5820-100-32, 6040-060-32, 5925-240-22, 6060-300-22, 5830-120-12, 60120-040-22, 5830-180-22, 6080-150-22, 6050-040-12, 6080-060-22
Primary DI / UDI-DI
06934955932380, 06934955930935, 06934955931543, 06934955931734, 06934955931109, 06934955931680, 06934955930676, 06934955931444, 06934955937460, 06934955930539, 06934955937552, 06934955930171, 06934955937668, 06934955929717, 06934955933899, 06934955934216, 06934955930249, 06934955931277, 06934955930973, 06934955930119, 06934955932021, 06934955933417, 06934955933011, 06934955930270, 06934955936876, 06934955932083, 06934955931956, 06934955936807, 06934955937910, 06934955939860, 06934955933677, 06934955934070, 06934955930751, 06934955937026, 06934955931932, 06934955938337, 06934955931826, 06934955929670, 06934955930256, 06934955937194, 06934955932885, 06934955931970, 06934955934063, 06934955937989, 06934955933691, 06934955930003, 06934955933929, 06934955931123, 06934955933820, 06934955932922, 06934955933790
Basic UDI-DI
069349559582GZ, 69349559582ZV
Direct Marketing DI
06934955932380
06934955930935
06934955931543
06934955931734
06934955931109
06934955931680
06934955930676
06934955931444
06934955937460
06934955930539
06934955937552
06934955930171
06934955937668
06934955929717
06934955933899
06934955934216
06934955930249
06934955931277
06934955930973
06934955930119
06934955932021
06934955933417
06934955933011
06934955930270
06934955936876
06934955932083
06934955931956
06934955936807
06934955937910
06934955939860
06934955933677
06934955934070
06934955930751
06934955937026
06934955931932
06934955938337
06934955931826
06934955929670
06934955930256
06934955937194
06934955932885
06934955931970
06934955934063
06934955937989
06934955933691
06934955930003
06934955933929
06934955931123
06934955933820
06934955932922
06934955933790
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000011345
FDA applicant
OrbusNeich Medical (Shenzhen) Co., Ltd.
Authorised representative
Quality First International OÜ EE-AR-000004308

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from OrbusNeich Medical (Shenzhen) Co., Ltd

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Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No